Stock Analysis

Why Apellis Pharmaceuticals (APLS) Is Up 10.9% After Positive EMPAVELI VALIANT Kidney Data And FDA Nod

  • Apellis Pharmaceuticals recently reported positive Phase 3 VALIANT results for EMPAVELI in C3 glomerulopathy and primary IC-MPGN, published in The New England Journal of Medicine, following its July 2025 FDA approval for patients aged 12 and older.
  • The data show a meaningful reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits, potentially strengthening EMPAVELI’s clinical profile and supporting broader physician confidence in complement inhibition for rare kidney diseases.
  • We’ll now examine how these VALIANT results and the FDA approval for EMPAVELI in C3 glomerulopathy could reshape Apellis Pharmaceuticals’ investment narrative.

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Apellis Pharmaceuticals Investment Narrative Recap

To own Apellis, you need to believe that complement inhibition can support a durable, profitable rare disease and ophthalmology franchise, with EMPAVELI and SYFOVRE both contributing. The positive VALIANT data in The New England Journal of Medicine and the July 2025 FDA approval for C3 glomerulopathy slightly de-risk EMPAVELI’s kidney opportunity, but near term the biggest swing factor still looks like SYFOVRE’s uptake, while reimbursement and patient access remain key pressure points.

Among recent announcements, Apellis’s strong Q3 2025 results, with revenue of US$458.58 million and net income of US$215.72 million, stand out in this context. They underline how meaningful new indications like C3 glomerulopathy could be if EMPAVELI can add to an already profitable base, although the company still faces significant competitive and pricing pressure in both geographic atrophy and rare nephrology markets.

Yet investors should also be aware that growing reliance on SYFOVRE in a competitive market could...

Read the full narrative on Apellis Pharmaceuticals (it's free!)

Apellis Pharmaceuticals’ narrative projects $1.2 billion revenue and $130.6 million earnings by 2028.

Uncover how Apellis Pharmaceuticals' forecasts yield a $35.39 fair value, a 50% upside to its current price.

Exploring Other Perspectives

APLS Community Fair Values as at Dec 2025
APLS Community Fair Values as at Dec 2025

Three Simply Wall St Community fair value estimates for Apellis span roughly US$35 to US$87 per share, showing how far apart individual views can be. You may want to weigh that dispersion against the reliance on SYFOVRE growth in a crowded market and consider how different scenarios for that product could affect Apellis’s longer term earnings power.

Explore 3 other fair value estimates on Apellis Pharmaceuticals - why the stock might be worth just $35.39!

Build Your Own Apellis Pharmaceuticals Narrative

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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About NasdaqGS:APLS

Apellis Pharmaceuticals

A commercial-stage biopharmaceutical company, focuses on the discovery, development, and commercialization of novel therapeutic compounds to treat diseases with high unmet needs.

Adequate balance sheet with moderate growth potential.

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